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Purpose: To describe a novel configuration of venous access for the performance of intermittent apheresis.
Participants: 20 participants at UNC who were referred for change from a vortex port to a powerflow port.
Procedures (methods): Placement of one of two configurations of the powerflow port and follow up visits between January 1, 2019 and December 31, 2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PowerPort Subjects | This study will involve a chart review of patients at UNC who were referred for change from a vortex port to a powerflow port. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PowerPort | Device | The study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Flow Rate | The study will compare mean change flow rate for pheresis sessions with the old system versus pheresis sessions with one of two new configurations by averaging the flow rate for up to 5 sessions using the new port configuration. | 1 year following new port configuration placement |
| Change in Procedure Time | The study will compare mean change in procedure time for pheresis sessions with the old system versus pheresis sessions with one of two new configurations. | 1 year following new port configuration placement |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Use of Tissue Plasminogen Activator | The study will compare mean change in use of tissue plasminogen activator for pheresis sessions with the old system versus pheresis sessions with one of two new configurations. | 1 year following new port configuration placement |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 20 adults will be enrolled to this study. The study subjects will be recruited from adults who are scheduled to receive or have received a PowerFlow™ Implantable Apheresis IV Port in Vascular Interventional Radiology for their clinical care.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bream, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39105402 | Derived | Howlett MS, Hicks K, Park Y, Karafin MS, Bream PR Jr. Use of a novel configuration of ports for patients needing intermittent long-term apheresis. J Clin Apher. 2024 Aug;39(4):e22143. doi: 10.1002/jca.22143. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication
The investigator who proposes to use the data has received IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
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